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Cardiovascular DiseaseNCT01142908

Cardiovascular Intervention Improvement Telemedicine Study

A study testing Pharmacist CVD in people with Cardiovascular Disease and Hypertension, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cardiovascular disease (CVD) is the leading cause of death in the United States; more than 80% of veterans have > 2 risk factors for CVD. Our study is one of the first to examine the implementation of a tailored behavioral/educational self-management intervention in primary care clinics designed to improve CVD risk. Read more about this study

Who is it for?
Any age
Conditions the study is for
Cardiovascular Disease, Hypertension, Diabetes
What is being tested?
Pharmacist CVD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
428 participants
Where
1 siteUnited States
Study dates
1 Nov 2011to 22 May 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Enrolled in one of three Durham Veterans Affairs Medical Center (DVAMC) Primary Care Clinics affiliated with the hospital or the Raleigh Community-Based Outpatient Clinic (CBOC) for at least one year;
  • At least one visit to a primary care physician (PCP) at the Raleigh CBOC or Durham Veterans Affairs Medical Center (VAMC) associated primary care clinics in the previous 12 months;
  • Outpatient diagnostic code for hypertension and/or hypercholesterolemia and lab values indicating either poorly controlled BP levels (>150/90 Hg) AND/OR LDL (>130mg/dl) in the previous year.

Who cannot join

  • diagnosed with metastatic cancer,
  • diagnosed with dementia,
  • active diagnosis of psychosis,
  • treated with dialysis,
  • most recent creatinine lab level >2.5 or no creatinine lab value within past year
  • hospitalized for a stroke, heart attack, or had surgery for blocked arteries in the past 3 months,
Show all 15Show fewer
  • participating in another interventional trial,
  • not currently receiving care at the Durham VAMC or the Raleigh CBOC
  • resident of a nursing home,
  • hard time seeing type/printing on books, magazines articles, etc.
  • hard time hearing on the telephone
  • limited/no access to telephone
  • plans to move medical care from DVAMC or Raleigh CBOC in next 12 months
  • CVD care is currently being managed by a clinical pharmacist
  • HbA1C value in the last 90day > 10% and patient is currently not on an insulin regimen.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Durham VA Medical Center, Durham, NC

    Durham, North Carolina, 27705-3875

Other trials in United States

About this study

Cardiovascular disease (CVD) is the leading cause of death in the United States; more than 80% of veterans have > 2 risk factors for CVD. Our study is one of the first to examine the implementation of a tailored behavioral/educational self-management intervention in primary care clinics designed to improve CVD risk. The proposed study could result in a leap forward in CVD risk management among veterans for several reasons: 1) ) This is a novel extension of our previous interventions that have demonstrated improved BP, now designed to address multiple chronic conditions contributing to CVD risk, particularly hyperlipidemia and diabetes. The study focuses on both multiple CVD-related risk factor management and medication management 2) The intervention is multi-behavioral; it addresses patients' various health behavior (e.g., smoking, diet, and medication adherence). 3) Components of the intervention will include specific recommendations and transportability of intervention application software and tracking packages that will allow clinic managers to implement the intervention if it is effective.

Read the detailed description

Anticipated Impacts on Veteran's Healthcare: Cardiovascular disease (CVD) is the leading cause of death in the U.S.; more than 80% of veterans have > 2 risk factors for CVD. An intervention that addresses multiple CVD risk factors among high-risk veterans has the greatest potential to improve morbidity and mortality.

Project Background/Rationale: The proposed study will take place in two VA primary care clinics (1-Community-Based Outpatient Clinics and 1-primary care clinic affiliated with a hospital). We will improve CVD risk among veterans by addressing the modifiable risk factors of systolic blood pressure (SBP), smoking, and low-density lipoprotein cholesterol (LDL-C). The intervention will be tailored to the needs of vulnerable high risk patients (e.g. African Americans, low literate) and integrated into clinics, thereby enhancing the potential for benefit and generalizability to other settings.

The proposed study could significantly improve CVD risk management among veterans for several reasons: 1) This intervention is a novel extension of our previous efficacious interventions, but provides a novel extension to address multiple chronic conditions contributing to CVD risk. 2) The intervention focuses on both multiple CVD-related behaviors and medication management. 3) The intervention was developed to ensure implementation across a large and representative sample of veterans; and; 4) The intervention, if found efficacious and financially self-sustaining, could be widely implemented within the VA healthcare system.

Project Objectives: The proposed study will examine two research questions:

  1. Can patients randomized to a clinical pharmacist-administered telephone behavioral/ medication management intervention tailored to their needs improve CVD outcomes relative to a control group over 12 months? Primary Hypothesis: (H1) Veterans who receive the behavioral/medication intervention will have greater improvement of their CVD Risk Profile over the 12 months of follow-up as compared to the control group. Secondary Hypotheses: (H2) Veterans who receive the intervention will have improved medication adherence, physical activity, improved diet, lower body mass index as compared to the control group over 12 months of follow-up. (H3) Veterans who receive the intervention will have greater improvements in LDL over the 12 months of follow-up as compared to the control group. (H4) Veterans with diabetes who receive the intervention will have greater improved HbA1c as compared to the control group over 12 months of follow-up.
  2. If the intervention is found to be effective, is it cost effective? Project Methods: To address these hypotheses, we propose a two-arm randomized clinical trial design in which 500 patients with cardiovascular disease will be randomized to either the education control group or the intervention group. Patients randomized to the intervention group will receive a clinical pharmacist-administered intervention, which focuses on behavioral and a medication management. The intervention will occur over 12 months. Patients randomized to the control group will receive educational material about CVD reduction. Given the national prevalence of CVD and the dismal rates of risk factor control, intensive, but easily disseminated interventions such as the one proposed could significantly improve treatment of this epidemic in the VA.
Being tested
Pharmacist CVD
Keywords
Cardiovascular Disease, Hypertension, Diabetes, Hyperlipidemia, Adherence
Medical subject headings
Cardiovascular Diseases, Hypertension, Diabetes Mellitus, Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pharmacist CVDBehavioural

    clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.

Study groups in NCT01142908
Study groupRoleWhat they receive
Arm 1ExperimentalThe pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
Receives: Behavioral: Pharmacist CVD
Arm 2No interventionThe education control group - these participants will receive educational material about CVD reduction.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)

    Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point [combination of administrative med data pull and self-report at assessment]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and VA Computerized Patient Record System (CPRS) data review). "New cases" of diabetes are allowed to be updated at 6 and 12 months f/u.

    Measured: Baseline

  2. Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)

    Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point [combination of administrative med data pull and self-report at assessment]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and CPRS data review). "New cases" of diabetes are allowed to be updated at 6 and 12 months f/u.

    Measured: 6 months

  3. Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)

    Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point [combination of administrative med data pull and self-report at assessment]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and CPRS data review). "New cases" of diabetes are allowed to be updated at 6 and 12 months f/u.

    Measured: 12 months

Secondary outcomes (18)

  1. Mean Systolic Blood Pressure

    Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

    Measured: Baseline

  2. Mean Systolic Blood Pressure

    Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

    Measured: 6 months

  3. Mean Systolic Blood Pressure

    Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

    Measured: 12 months

  4. Mean Diastolic Blood Pressure

    Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

    Measured: Baseline

  5. Mean Diastolic Blood Pressure

    Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

    Measured: 6 months

  6. Mean Diastolic Blood Pressure

    Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

    Measured: 12 months

  7. Medication Non-adherence

    First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.

    Measured: Baseline

  8. Medication Non-adherence

    First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.

    Measured: 6 months

  9. Medication Non-adherence

    First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.

    Measured: 12 months

  10. Cholesterol LDL

    Collected during interview visit by lab personnel

    Measured: Baseline

  11. Cholesterol LDL

    Collected during interview visit by lab personnel

    Measured: 6 months

  12. Cholesterol LDL

    Collected during interview visit by lab personnel

    Measured: 12 months

  13. Body Mass Index

    Calculated from vitals (height \& weight) obtained during interview

    Measured: Baseline

  14. Body Mass Index

    Calculated from vitals (height \& weight) obtained during interview

    Measured: 6 months

  15. Body Mass Index

    Calculated from vitals (height \& weight) obtained during interview

    Measured: 12 months

  16. HBA1C in Diabetic Patients

    Lab values collected at interview visit by lab personnel

    Measured: Baseline

  17. HBA1C in Diabetic Patients

    Lab values collected at interview visit by lab personnel

    Measured: 6 months

  18. HBA1C in Diabetic Patients

    Lab values collected at interview visit by lab personnel

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2010 (estimated)
  2. Study start1 Nov 2011
  3. Primary completion30 Apr 2015
  4. Study completion22 May 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
428 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01142908
Sponsor's protocol ID
IIR 08-297
Other IDs
08-297
Status last verified
Jul 2023
First submitted
24 May 2010
Last updated
27 Jul 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Goldstein KM, Stechuchak KM, Zullig LL, Oddone EZ, Olsen MK, McCant FA, Bastian LA, Batch BC, Bosworth HB. Impact of Gender on Satisfaction and Confidence in Cholesterol Control Among Veterans at Risk for Cardiovascular Disease. J Womens Health (Larchmt). 2017 Jul;26(7):806-814. doi: 10.1089/jwh.2016.5739. Epub 2017 Feb 13.

    PubMed 28192012

  • Goldstein KM, Oddone EZ, Bastian LA, Olsen MK, Batch BC, Washington DL. Characteristics and Health Care Preferences Associated with Cardiovascular Disease Risk among Women Veterans. Womens Health Issues. 2017 Nov-Dec;27(6):700-706. doi: 10.1016/j.whi.2017.08.002. Epub 2017 Sep 8.

    PubMed 28890128

  • Bosworth HB, Olsen MK, McCant F, Stechuchak KM, Danus S, Crowley MJ, Goldstein KM, Zullig LL, Oddone EZ. Telemedicine cardiovascular risk reduction in veterans: The CITIES trial. Am Heart J. 2018 May;199:122-129. doi: 10.1016/j.ahj.2018.02.002. Epub 2018 Feb 10.

    PubMed 29754649

  • Melnyk SD, Zullig LL, McCant F, Danus S, Oddone E, Bastian L, Olsen M, Stechuchak KM, Edelman D, Rakley S, Morey M, Bosworth HB. Telemedicine cardiovascular risk reduction in veterans. Am Heart J. 2013 Apr;165(4):501-8. doi: 10.1016/j.ahj.2012.08.005. Epub 2013 Feb 28.

    PubMed 23537965

  • Zullig LL, Melnyk SD, Stechuchak KM, McCant F, Danus S, Oddone E, Bastian L, Olsen M, Edelman D, Rakley S, Morey M, Bosworth HB. The Cardiovascular Intervention Improvement Telemedicine Study (CITIES): rationale for a tailored behavioral and educational pharmacist-administered intervention for achieving cardiovascular disease risk reduction. Telemed J E Health. 2014 Feb;20(2):135-43. doi: 10.1089/tmj.2013.0145. Epub 2013 Dec 4.

    PubMed 24303930

  • Zullig LL, Stechuchak KM, Goldstein KM, Olsen MK, McCant FM, Danus S, Crowley MJ, Oddone EZ, Bosworth HB. Patient-reported medication adherence barriers among patients with cardiovascular risk factors. J Manag Care Spec Pharm. 2015 Jun;21(6):479-85. doi: 10.18553/jmcp.2015.21.6.479.

    PubMed 26011549

  • Palmer MJ, Machiyama K, Woodd S, Gubijev A, Barnard S, Russell S, Perel P, Free C. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012675. doi: 10.1002/14651858.CD012675.pub3.

    PubMed 33769555

  • Ulmer CS, McCant F, Stechuchak KM, Olsen M, Bosworth HB. Prevalence of insomnia disorder and sleep apnea in a sample of veterans at risk for cardiovascular disease. J Clin Sleep Med. 2021 Jul 1;17(7):1441-1446. doi: 10.5664/jcsm.9228.

    PubMed 33688827

  • Zullig LL, Oakes MM, McCant F, Bosworth HB. Lessons learned from two randomized controlled trials: CITIES and STOP-DKD. Contemp Clin Trials Commun. 2020 Jul 8;19:100612. doi: 10.1016/j.conctc.2020.100612. eCollection 2020 Sep.

    PubMed 32685766

  • Goldstein KM, Melnyk SD, Zullig LL, Stechuchak KM, Oddone E, Bastian LA, Rakley S, Olsen MK, Bosworth HB. Heart matters: Gender and racial differences cardiovascular disease risk factor control among veterans. Womens Health Issues. 2014 Sep-Oct;24(5):477-83. doi: 10.1016/j.whi.2014.05.005.

    PubMed 25213741

Questions about this trial

What is this clinical trial studying?

A study testing Pharmacist CVD in people with Cardiovascular Disease and Hypertension, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01142908, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.

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Clinical Trial NCT01142908 | AzTrials